Status: Ongoing First registered on: 10/12/2013
Last updated on: 11/12/2015
1. Study identification
EU PAS Register NumberEUPAS5383
Official titleCAncer Risk and INsulin analoGues
Study title acronymCARING
Study typeObservational study
Brief description of the studyThe CARING (CAncer Risk and INsulin analoGues) project will obtain precise data on the incidence of cancer in diabetic patients and determine any link with use of various insulin and insulin analogues. The study will utilise high quality prescription databases and other national data sources, integrated at European level with advanced methods of harmonising data. The study will take into account potential confounders. The project aims to determine the influence of drug dose on risk, and through a risk model, identify predictors of cancer for insulin users. A review of published evidence combined with a study of tumour characteristics and gene expression in breast cancer tumour collections will aid understanding of potential mechanisms of cancer initiation and/or promotion by insulin.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/science/pharmacoepidemiology
Details of (Primary) lead investigator
Title Dr
Last name De Bruin
First name Marie L
Is this study being carried out with the collaboration of a research network?
Yes

CARING
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

Centre for Pharmacoepidemiology (CPE)
Utrecht University Pharmacoepidemiology Center
NIPH
Aarhus University Hospital, Aarhus, Denmark
University of Tampere, Tampere, Finland
University of Helsinki, Helsinki, Finland
Netherlands Cancer Institute, Amsterdam, Netherlands
Countries in which this study is being conducted
International study

Denmark
Finland
Netherlands
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/07/201118/07/2011
Start date of data collection01/11/201101/11/2011
Start date of data analysis01/08/201401/08/2014
Date of interim report, if expected
Date of final study report04/01/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeFP7 HEALTH.2011.4.2-2100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name De Bruin
First name Marie L
Address line 1Univeristeitsweg 99
Address line 2 
Address line 3 
CityUtrecht 
Postcode3584 CG 
CountryNetherlands
Phone number (incl. country code)31-30-2537324 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address m.l.debruin@uu.nl
Public Enquiries
Title Dr 
Last name De Bruin 
First name Marie L 
Address line 1Univeristeitsweg 99 
Address line 2 
Address line 3 
CityUtrecht 
Postcode3584 CG 
CountryNetherlands 
Phone number (incl. country code)31-30-2537324 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address m.l.debruin@uu.nl 
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